Astelin

"What are allergies?

Allergies occur when the body's immune system responds to a substance it considers an "invader." Substances that provoke the immune system into an allergic response are known as allergens. There is no such thing as a"...

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely
varying conditions, adverse reaction rates observed in clinical trials of a
drug cannot be directly compared to rates in the clinical trials of another
drug and may not reflect rates observed in practice.

Seasonal Allergic Rhinitis

Astelin Nasal Spray Two Sprays Per Nostril Twice Daily

Adverse experience information for Astelin Nasal Spray is
derived from six placebo-and active-controlled, 2-day to 8-week clinical trials
which included 391 patients, 12 years of age and older, with seasonal allergic
rhinitis who received Astelin Nasal Spray at a dose of 2 sprays per nostril
twice daily. In placebo-controlled efficacy trials, the incidence of
discontinuation due to adverse reactions in patients receiving Astelin Nasal
Spray and vehicle placebo was 2.2% and 2.8%, respectively.

Table 1 contains adverse reactions that were reported
with frequencies ≥ 2% in the Astelin Nasal Spray 2 sprays per nostril
twice daily treatment group and more frequently than placebo.

Astelin Nasal Spray One
Spray Per Nostril Twice Daily

Adverse experience information
for Astelin Nasal Spray at a dose of one spray per nostril twice daily is
derived from two placebo-controlled 2-week clinical studies which included 276
patients 12 years of age and older with seasonal allergic rhinitis. The
incidence of discontinuation due to adverse reactions in patients receiving
Astelin Nasal Spray and vehicle placebo was 0.0% and 0.8%, respectively. Bitter
taste was reported in 8.3% of patients compared to none in the placebo group.
Somnolence was reported in 0.4% of patients compared to none in the placebo
group.

A total of 176 patients 5 to 11
years of age were exposed to Astelin Nasal Spray at a dose of 1 spray each
nostril twice daily in 3 placebo-controlled studies. In these studies, adverse
reactions that occurred more frequently in patients treated with Astelin Nasal
Spray than with placebo, and that were not represented in the adult adverse
reactions table above include rhinitis/cold symptoms (17.0% vs. 9.5%), cough
(11.4% vs. 8.3%), conjunctivitis (5.1% vs. 1.8%), and asthma (4.5% vs. 4.1%).

Adverse Reactions < 2% in
Astelin Nasal Spray One or Two Sprays Per Nostril Twice Daily

The following reactions were
observed infrequently ( < 2% and exceeding placebo incidence) in patients who
received Astelin Nasal Spray dosed at 1 or 2 sprays per nostril twice daily in
U.S. clinical trials.

Vasomotor Rhinitis

Adverse experience information for Astelin Nasal Spray is
derived from two placebo-controlled clinical studies which included 216
patients 12 years and older with vasomotor rhinitis who received Astelin Nasal
Spray at a dose of 2 sprays per nostril twice daily for up to 28 days. The
incidence of discontinuation due to adverse reactions in patients receiving
Astelin Nasal Spray and vehicle placebo was 2.8% and 2.9%, respectively.

The following adverse reactions were reported with
frequencies ≥ 2% in the Astelin Nasal Spray treatment group and more
frequently than placebo.

Reactions observed infrequently
( < 2% and exceeding placebo incidence) in patients who received Astelin Nasal
Spray (2 sprays/nostril twice daily) in U.S. clinical trials in vasomotor
rhinitis were similar to those observed in U.S. clinical trials in seasonal
allergic rhinitis.

DRUG INTERACTIONS

Central Nervous System Depressants

Concurrent use of Astelin Nasal Spray with alcohol or
other central nervous system depressants should be avoided because reductions
in alertness and impairment of central nervous system performance may occur [see
WARNINGS AND PRECAUTIONS].